Sentinel Query Builder Tool for the FDA

FDA

Web and Mobile Application Development

Real World Evidence

Research Studies

About

Sentinel System is the U.S. Food and Drug Administration’s (FDA’s) national electronic system to monitor the post-market safety of FDA-regulated medical products (e.g., drugs, vaccines, biologics, and medical devices).

Sentinel maintains access to electronic healthcare data, such as electronic health records (EHR), insurance claims data, and registries, from a number of data partners. The FDA uses this data to monitor the effects of the products they approve/regulate once they go to market.

Specifically, the FDA researchers retrieved healthcare data on how the products have been used to conduct studies. This required the FDA to create a request with Sentinel for defining query parameters, some of which were determined by the FDA and others by Sentinel staff.

However, this was a long and tedious process since there were around 183 parameters to define, and the process involved sharing questions and answers via Excel sheet.

The Challenge

  • Understand the nuances of the entire process and the specific tasks of the stakeholders to deliver an efficient solution.
  • Create a faster and more user-friendly way for FDA scientists to create medical product usage queries and retrieve data for conducting studies.
  • Ensure the safety of sensitive patient data and follow healthcare industry standards such as HIPAA.

The Solution

  • We analyzed the processes and the concepts related to the initiative, including the query/cohort identification strategy and key parameters.
  • BTC developed a first-of-its-kind and secure web-based query design tool, ‘Sentinel Query Builder,’ for FDA that allowed users to create medical-product utilization queries and convert them into Sentinel query request packages in SAS®, a software system for data analysis and visualization.
  • The query included predefined parameters to identify cohort(s) who meet the criteria to participate in the study conducted by the FDA epidemiologists.
  • The tool created a Cohort Identification and Descriptive Analysis (CIDA) SAS® query request package that can be executed against any data formatted into the Sentinel Common Data Model (SCDM).
  • Sentinel Query Builder can also be downloaded to users’ computers to construct and generate Sentinel query request packages.
  • The queries were retrieved in JSON (JavaScript Object Notation) format within the tool and converted directly into Sentinel query request packages using the Query Builder JSON conversion program.
  • We built an intuitive interface that helped users view, edit, create, and submit queries. It dynamically updated itself everytime the inbuilt programs of Query Builder tool modified parameter sets for the queries created by users.
  • The application allowed the FDA personnel to define their own limited set of query parameters, eliminating the arduous task of communicating with the Sentinel staff.
  • The tool prevented undue exposure of sensitive information by adhering to industry regulations, including HIPAA, 21 CFR Part II, and FISMA grade security controls.

Technology:

Java
React.js
Node.js
FDA MyStudies

 

Options for creating a query in FDA Sentinel Query Builder tool by BTC

The Outcome

  • BTC’s Sentinel Query Builder tool allowed the users to create and submit valid queries on medical product utilization.
  • The tool eliminated the process of sharing Excel sheets, which accelerated the entire query request process for collecting data, helping improve medical product safety.

 

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